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Interest of Self-compression Technique on Tolerance of Mammography (ITACTs)

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ClinicalTrials.gov Identifier: NCT02866591
Recruitment Status : Completed
First Posted : August 15, 2016
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Institut de Cancérologie de Lorraine

Brief Summary:

Mammography is used for screening, diagnosis, therapeutic evaluation and monitoring of local cancer breast.

It is sometimes poorly tolerated by some patients who complain of an uncomfortable examination or pain.

Breast compression by the manipulator aims to reduce the thickness of the breast during mammography; This act is an important factor of pain or discomfort felt by the patient. But, it is also an image quality factor.

This study aimed to compare self-breast compression by the patient to the compression standard technique carried out by the manipulator.


Condition or disease Intervention/treatment Phase
Breast Cancer Other: mammography according to an auto-compression procedure Other: mammography according to a standard procedure Other: questionary Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Interest of Self-compression Technique on Tolerance of Mammography
Actual Study Start Date : May 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mammography

Arm Intervention/treatment
Experimental: Arm A
Patients have a mammography performed by themselves according to auto-compression procedure. The radiologist leads the compression at a minimum threshold of 40 Newton, then leaves the control of the compression to the patient. The radiologist treats only the positioning of the breast on the sensor.
Other: mammography according to an auto-compression procedure
Other: questionary
Active Comparator: Arm B
Patients have a mammography performed by the radiologist according to standard procedure.
Other: mammography according to a standard procedure
Other: questionary



Primary Outcome Measures :
  1. Comparison of two breast compression techniques (auto-compression versus standard procedure) in mammography [ Time Frame: 1 day ]
    The comparison will be evaluated by the thickness (mm) of breast compressed


Secondary Outcome Measures :
  1. Overall tolerance of mammography [ Time Frame: 1 day ]
    The overall tolerance of mammography will be assessed by the patient after 4 shots. The pain felt by the patient will be assessed using a visual analog scale.

  2. Breast compression force [ Time Frame: 1 day ]
    Value measured on compressive force console (Newtons)

  3. Thickness / compressing force ratio [ Time Frame: 1 day ]
  4. Image quality [ Time Frame: 1 day ]
    The image quality will be assessed by the radiologist with a quotation of motion blurring on a 4-point scale

  5. Overall assessment of the manipulator [ Time Frame: 1 day ]
    The appreciation of the manipulator will be assessed using a 4-point scale

  6. Overall assessment of self-satisfaction of the patient at the end of the examination [ Time Frame: 1 day ]
    The measurement of patient satisfaction will be evaluated using a self-administered Norwegian questionnaire (MammoGraphy Questionnaire)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients ≥ 18 years and ≤ 75 years of age
  • ECOG performance <2
  • Mammography planned as part of a breast cancer screening or a monitoring following treatment of a breast lesion
  • Ability to provide written informed consent
  • Patient's legal capacity to consent to study participation and to understand and comply with the requirements of the study.

Exclusion Criteria:

  • Eastern Cooperative Oncology Group performance status ≥ 2
  • Treatment for benign lesion with surgery for less than 3 years
  • Treatment for cancer with surgery and / or radiotherapy for less than 3 years
  • Biopsy for less than 1 year
  • Breast prosthesis
  • Mastectomy
  • Assessment motivated by a clinical breast abnormality

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866591


Locations
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France
Institut Bergonié
Bordeaux, France, 33000
Centre François Baclesse
Caen, France, 14076
Cabinet de radiologie
Nancy, France, 54000
Polyclinique Majorelle
Nancy, France, 54000
Institut Curie
Paris, France, 75248
Institut de Cancérologie de Lorraine
Vandoeuvre-les-Nancy, France, 54519
Sponsors and Collaborators
Institut de Cancérologie de Lorraine
Investigators
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Principal Investigator: HENROT Philippe, MD Institut de Cancérologie de Lorraine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Institut de Cancérologie de Lorraine
ClinicalTrials.gov Identifier: NCT02866591     History of Changes
Other Study ID Numbers: 2012-A00248-35
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Institut de Cancérologie de Lorraine:
mammography
pain
quality of life
screening
image quality
radiology